D9319C00001- 1L OC Mono Global RCT

  • STATUS
    Recruiting
  • End date
    Jul 2, 2025
  • participants needed
    420
  • sponsor
    AstraZeneca
Updated on 16 September 2021
measurable disease
bevacizumab
cancer chemotherapy
olaparib
fallopian tube
platinum-based chemotherapy
cancer antigen 125
peritoneal cancer
tumor debulking
cancer of the ovary
primary debulking surgery
interval debulking surgery

Summary

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of maintenance olaparib compared with placebo in BRCAwt participants with Stage III to IV high grade serous or endometroid ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who are in complete or partial response following treatment with standard first-line platinum-based chemotherapy.

Details
Condition Ovarian disorder, Ovarian Cancer, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, ovarian tumors
Treatment olaparib, Matching Placebo
Clinical Study IdentifierNCT04884360
SponsorAstraZeneca
Last Modified on16 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must be 18 years at the time of (pre-)screening
Histological and staging criteria:Female participants who must have
histologically newly diagnosed high-grade serous or endometrioid ovarian
cancer, fallopian tube cancer, or primary peritoneal cancer that is Stage III
or IV according to the International FIGO 2009
Participants are eligible if they fulfil any of the following surgical
criteria
Stage III: primary debulking surgery with macroscopic residual disease post-surgery, neoadjuvant chemotherapy, or inoperable
Stage IV: primary debulking surgery regardless of residual disease, neoadjuvant chemotherapy, or inoperable
Chemotherapy criteria
Participants must have received platinum-based chemotherapy consisting of a minimum of 6 treatment cycles and a maximum of 9, however, if platinum-based therapy must be discontinued early as a result of toxicities specifically related to the platinum regimen, participants must have received a minimum of 4 cycles of the platinum regimen
Participants must have, in the opinion of the investigator, clinical CR or PR as per RECIST 1.1 criteria with no measurable lesion > 2 cm on the post-treatment scan and have no clinical evidence of disease progression or a rising CA-125 level (see inclusion criterion 5), following completion of this chemotherapy course
A participant who received interval debulking surgery must have had 2 postoperative cycles of platinum-based therapy
Participants must meet one of the criteria specified below for pre-
treatment CA-125 measurements as follows
CA-125 in the normal range or
CA-125 decrease by 90% during their front-line therapy that is stable for at least 7 days (ie, no increase > 15% from nadir. If the first value is greater than the upper limit of normal (ULN), a second assessment must be performed at least 7 days after the first. If the second assessment is > 15% more than the first value, the participant is not eligible)
Participants should not have received bevacizumab with first-line
chemotherapy or be planned to receive bevacizumab maintenance therapy
ECOG performance status of 0 or 1 with no deterioration over the previous 2
weeks prior to randomisation
Provision, at pre-screening, of a formalin-fixed, paraffin-embedded (FFPE)
tumour sample to assess tBRCA status and for HRD testing centrally. The
centrally performed tBRCA test results must be available prior to
randomisation and must indicate that the participant has a BRCAwt tumour
defined by the absence of a deleterious or suspected deleterious BRCA mutation
by central testing
Adequate organ and marrow function

Exclusion Criteria

Participants with stable disease or progressive disease on the post-treatment scan or clinical evidence of progression at the end of the participant's first-line chemotherapy treatment, or any evidence of progressive disease prior to randomization
Participant has mucinous or clear cell subtypes of epithelial ovarian
cancer, carcinosarcoma, undifferentiated ovarian cancer, non-epithelial
ovarian cancer, borderline tumours or low grade epithelial ovarian tumours
(applies to fallopian tube and primary peritoneal tumours where applicable)
Participants with Stage III disease who have had complete cytoreduction
(ie, no macroscopic residual disease) at their primary debulking surgery
Participants who have undergone 2 debulking (cytoreductive) surgeries
History of another primary malignancy except for malignancy treated with
curative intent with no known active disease 5 years before the first dose of
study intervention including adequately treated non-melanoma skin cancer
curatively treated in situ cancer of the cervix, ductal carcinoma in situ
(DCIS), Stage 1, Grade 1 endometrial carcinoma. Participants with a history of
localised triple negative breast cancer may be eligible, provided they
completed their adjuvant chemotherapy more than three years prior to
registration, and that the participant remains free of recurrent or metastatic
disease
Persistent toxicities (CTCAE Grade 2) caused by previous anticancer
therapy, excluding alopecia and CTCAE Grade 2 peripheral neuropathy
Participants with irreversible toxicity that is not reasonably expected to be
exacerbated by study intervention may be included after consultation with the
AstraZeneca study physician
Participant is immunocompromised
Prior exposure to a PARP inhibitor, including olaparib
Any concurrent anticancer treatment
Currently pregnant or breast-feeding
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